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A double-masked randomized cross-over study comparing the effect of Xalacom (latanoprost/timolol) and Combigan (brimonidine/timolol) fixed combination on intraocular pressure and ocular blood flow in patients with primary open angle glaucoma or ocular hypertension

A double-masked randomized cross-over study comparing the effect of Xalacom (latanoprost/timolol) and Combigan (brimonidine/timolol) fixed combination on intraocular pressure and ocular blood flow in patients with primary open angle glaucoma or ocular hypertension

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-004060-24-AT
Enrollment
Unknown
Registered
2005-10-20
Start date
2005-11-24
Completion date
Unknown
Last updated
2013-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Interventions

Trade Name: Xalacom Pharmaceutical Form: Eye drops* Trade Name: Combigan Pharmaceutical Form:

Sponsors

Department of Clinical Pharmacology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Men and women >= 18 years Unilateral or bilateral primary open angle glaucoma, ocular hypertension, exfoliation glaucoma, pigmentary glaucoma with IOP >= 22 -35mmHg At least 3 reliable visual field testings Washout period: 4 weeks for ß adrenergic receptor antagonists and prostaglandin analogues, 2 weeks for adrenergic agonists, and 5 days for cholinergic agonists and carbonic anhydrase inhibitors Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: History of acute angle closure Closed or barely open anterior chamber angle Standard deviation of visual field testing > 10 Intraocular surgery or argon laser trabeculoplasty within the last six months Ocular inflammation or infection within the last three months Contact lenses Patients with bradycardia (heart rate < 50 beats/min) Second and third degree heart block Asthma COPD Congestive heart failure Severe renal impairment (creatinine clearance < 1.8 L/h) History of hypersensitivity to one of the study drugs or drugs with similar chemical structure Topical or systemical/oral therapy with steroids History of non-IOP responder to beta-blockers, alpha-2 adrenergic or prostaglandin analogues Pregnancy

Design outcomes

Primary

MeasureTime frame
Main Objective: To compare the effect of a 6 weeks treatment with Xalacom® (latanoprost/timolol) and Combigan® (brimonidine/timolol) fixed combination on intraocular pressure and ocular blood flow in patients with primary open angle glaucoma or ocular hypertension.;Secondary Objective: ;Primary end point(s): Study treatment is stopped after 12 weeks—

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026